FDA again warns against Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)
06 February 2019
| The Food and Drug Administration (FDA) wants to increase awareness about an association between all breast implants, regardless of filling or texture, and Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL). The FDA received reports indicating that patients with breast implants have an increased risk of developing this disease within the scar capsule adjacent to the implant. | |
| BIA-ALCL is a type of lymphoma and is not a cancer of the breast tissue….. The FDA’s additional data analysis identified 457 unique MDRs for BIA-ALCL, including the death of nine patients which may be attributable to BIA-ALCL….. Additionally, most of the published information about treatment describes removal of the implant and the capsule surrounding the implant, and in some patients, treatment with chemotherapy and radiation….. Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL……. |
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| Author(s) | Source |
| FDA | www.fda.gov, Feb 6, 2019 |
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